FDA grants Ethicon a breakthrough device designation for its transbronchial microwave ablation technology using robotic-assisted bronchoscopy.
Federal Register notice: FDA makes available a final guidance entitled Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products....
FDA accepts from Merck two supplemental BLAs for Keytruda (pembrolizumab) and its use in triple-negative breast cancer.
Eton Pharmaceuticals files an NDA for zonisamide oral suspension for treating partial seizures in patients with epilepsy.
FDA seeks comment on a proposal to add four bulk drug substances to the bulk list for drug compounders.
FDA grants Takeda Pharmaceutical a breakthrough therapy designation for its investigational drug pevonedistat for treating patients with higher-risk m...
Federal Register notice: FDA makes available a draft guidance entitled Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescripti...
FDA reminds patients, caregivers, and healthcare providers about the risks associated with deep brain stimulation devices when used to treat Parkinson...